Benzinga | Nov 17, 2021 08:31AM EST

Denali Therapeutics Announces Strategic Partner Takeda Exercises Option To Co-Develop And Co-Commercialize DNL593

Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that its strategic partner Takeda Pharmaceutical Company Limited ("Takeda") has exercised an option, pursuant to an existing collaboration agreement between the two companies, to co-develop and co-commercialize DNL593 (PTV:PGRN), an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin (FTD-GRN).

"We are excited to advance our collaboration with Takeda on the development of DNL593 as a potential treatment for people with FTD-GRN," said Denali's Chief Executive Officer, Ryan Watts, Ph.D. "Pending acceptance of regulatory submissions, DNL593 will be the sixth therapeutic candidate from our broad pipeline, and our second Transport Vehicle (TV)-enabled molecule, in clinical development. This progress underscores the potential of our TV platform technology, which is designed to enable and enhance delivery of biologic therapeutics to the brain for the treatment of neurodegenerative diseases."

"At Takeda, our focus is to develop transformative treatments for patients suffering from devastating neurologic disorders. One of the main challenges in the development of these medicines is to achieve adequate biodistribution in target tissues, and Denali has engineered a promising TV platform technology to transport biologic therapeutics across the BBB and into the brain," said Sarah Sheikh, BM BCh, MSc, MRCP, Head, Neuroscience Therapeutic Area Unit at Takeda. "Preclinical studies with DNL593 are encouraging and demonstrate that Protein Transport Vehicle (PTV) can enhance the uptake of peripherally administered progranulin (PGRN) by multiple cell types in the brain, including neurons and microglia. We look forward to working with Denali to deliver DNL593 as a potentially transformative treatment for people living with FTD-GRN."

In January 2018, Denali and Takeda entered into a collaboration agreement, pursuant to which Takeda was granted an option for three programs including PTV:PGRN. By exercising its option to the PTV:PGRN program, Takeda obtains the right to develop and commercialize DNL593 jointly with Denali. Denali will receive an option fee and may also receive future milestone payments upon achievement of certain clinical and regulatory milestone events as well as certain sales-based milestones. Subject to the terms of the collaboration agreement, the companies will share the development and commercialization costs equally, and, if applicable, profits on a worldwide basis.